BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS

    MDR report key: 5233820 · Received November 18, 2015

    Report

    Report Number
    3004154314-2013-00006
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    May 15, 2013
    Report Date
    October 26, 2015
    Manufacturer
    ARTHROSURFACE
    Product Code
    HSX
    PMA / PMN Number
    K050373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE HOLDER BROKE WHILE IN USE. THE PIECE WAS RETRIEVED AND THERE WAS NO HARM TO THE USER OR PATIENT. NO ISSUES RESULTED IN THE CASE. A MODIFICATION HAS BEEN PREVIOUSLY MADE TO INCREASE THE STRENGTH OF THE COMPONENT. THIS LOT WAS PRODUCED PRIOR TO THAT CHANGE BEING IMPLEMENTED.

    Description of Event or Problem · 1

    THE DISTAL TIP OF THE TIBIAL BLADE HOLDER INSTRUMENT BROKE WHILE BEING LOADED ONTO THE HANDLE. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764264 UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER HSX ARTHROSURFACE 2008-8010 75HH1802

    Patients

    Seq Age Sex Outcome Treatment
    1